Viewing Study NCT00453453



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00453453
Status: TERMINATED
Last Update Posted: 2015-02-09
First Post: 2007-03-28

Brief Title: BNP Therapy Observation Unit Outcomes STudy BOOST
Sponsor: Emory University
Organization: Emory University

Study Overview

Official Title: BNP Therapy Observation Unit Outcomes STudy
Status: TERMINATED
Status Verified Date: 2015-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BOOST
Brief Summary: The investigators hypothesize that patients admitted to an emergency department ED observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with nesiritide versus standard therapy The investigators also hypothesize that decreasing B-type Natriuretic Peptide BNP levels during treatment in an ED observation unit will predict improved patient outcomes
Detailed Description: Congestive heart failure CHF is a growing problem in the United States The increasing number of decompensated heart failure patients presenting to emergency departments ED for treatment is worsening the burden on already strained and limited health care resources In addition many of these patients will return to the ED for treatment within three months of being treated for decompensated heart failure The emergence of ED observation units has provided a viable and cost effective alternative to inpatient treatment for many diseases including CHF It has been shown that intensive directed therapy in ED observation units has decreased the revisit rates for CHF patients In addition the introduction of nesiritide has shown promising results in the treatment of decompensated congestive heart failure

The primary aim of this study is to compare nesiritide versus standard heart failure therapy in an ED setting A secondary aim is to determine if serial BNP levels during this observation unit stay will predict clinical outcomes

The treatment of heart failure in the ED places a tremendous burden on already limited resources The costs of treatment as well as the morbidity and mortality associated with the disease are worsening and are predicted to increase as the general population ages The ability to safely treat and discharge patients from an ED observation unit while reducing return visits would be invaluable in managing the growing number of heart failure patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
0009-2006 OTHER Other None